Clinical Trials Logo

Clinical Trial Summary

A phase III, randomized, multi-center clinical trial that will examine whether treatment with intravenous TNK is superior to placebo in patients who suffer a non-large vessel occlusion ischemic stroke within 4.5-12 hours from time last seen well. The randomization employs a 1:1 ratio of intravenous thrombolysis with Tenecteplase (TNK) versus placebo in patients who suffer a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours from time last seen well (TLSW) and have evidence of salvageable brain tissue on perfusion imaging.


Clinical Trial Description

Prospective, multi-center, randomized, controlled, double blinded trial with an adaptive design and population enrichment. The randomization employs a 1:1 ratio of intravenous thrombolysis with Tenecteplase (TNK) versus placebo in patients who suffer a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours from time last seen well (TLSW) and have evidence of salvageable brain tissue on perfusion imaging. Randomization will be done under a minimization process using age (≤70 vs. >70 years), baseline NIHSS (≤10 vs. >10), baseline infarct volume (≤15mL vs. >15-30mL vs. >30-50mL), perfusion mismatch volume (≤15mL vs. >15-30mL vs. >30-50mL), therapeutic window (4.5-9 or 9-12 hours after TLKW), and clinical site. The candidate enriched populations that the trial considers are based on time last known well (TLKW) to randomization (4.5-9 vs. 9-12 hours) and mismatch volumes as measured using Mismatch on MRP-DWI or CTP-rCBF maps (>40 cc vs. >30cc vs. >20cc vs. >10cc). For the primary endpoint, subjects will be followed for 90 days post-randomization. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05199662
Study type Interventional
Source Hospital Moinhos de Vento
Contact Gisele Sampaio Silva, MD, MPH, PhD
Phone 5511983580583
Email [email protected]
Status Recruiting
Phase Phase 3
Start date January 20, 2022
Completion date May 2024